CHEMIST, GS-1320-13


Vacancy ID: 742335   Announcement Number: HHS-FDA-CDER-MP-13-742335   USAJOBS Control Number: 325981800

Occupational/Assessment Questions:

1. Select the option below that BEST describes your education to meet the basic qualification.

A. I have a bachelor's degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics. (Must submit transcripts)
B. I have a combination of education and experience that included course work equivalent to a major as shown in "A" above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education. (Must submit transcripts)
C. I do not have the education described above.

2. Do you have at least one year of specialized experience (equivalent to the GS-12 level in the Federal service) that included assessing the quality and safety of human drug products; conducting analytical testing, development, or manufacturing of drugs; providing regulatory authority on chemistry and manufacturing controls (CMC) and/or pharmaceutical development and manufacturing; and interpreting and evaluating the results of analytical testing?

A. Yes, I have the experience described above.
B. No, I do not have the experience described above.

For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.

A- I have no experience in performing this work behavior.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

3. Perform risk-based assessments of Chemistry, Manufacturing, and Controls (CMC) information used to manufacture drug substances and products.

4. Evaluate the adequacy of manufacturing facilities, synthesis processes, and in-process controls used to characterize and manufacture drug substances and products.

5. Identify critical quality attributes of drug products as they relate to drug product performance, safety, and effectiveness.

6. Develop chemical or physical assay methods and evaluate their validity and adequacy.

7. Apply knowledge of pharmaceutical dosage forms to their development including one or more of the following dosage forms: tablets, capsules, creams, lotions, solutions, transdermal patches, etc.

8. Apply drug labeling laws and regulations to drug product labeling.

9. Make recommendations regarding scientific and regulatory acceptability of proposed drug manufacturing, processes, and controls.

10. Attend conferences and technical meetings to exchange ideas with other scientists.

11. Present information and findings to internal and external customers, supervisors and senior level management at meetings.

12. Participate in the resolution of scientific disagreements through the development of acceptable compromises or suitable alternatives.

13. Respond verbally to complex questions and participate in integrated discussions regarding technical information and comprehensive summaries of conclusions and regulatory recommendations.

14. Communicate effectively with a variety of employees and other individuals working at all levels of management.